The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.

Time to first occurrence of any of the following adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) or non-fatal stroke [ Time Frame: 432 weeks ]

Secondary Outcome Measures:

Time to first occurrence of any of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke or hospitalisation for unstable angina pectoris [ Time Frame: 432 weeks ]

Proportion of patients on study treatment at study end, that at Final Visit maintain glycemic control (HbA1c <= 7.0%) without need for rescue medication, without any moderate/severe hypoglycaemic episodes and without > 2% weight gain (from V6 on) [ Time Frame: 432 weeks ]

Occurence of any of the adjudicated components of the composite primary and composite first key secondary endpoint. [ Time Frame: 432 weeks ]

Transitions in albuminuria classes between baseline and Final visit. [ Time Frame: 432 weeks ]

Proportion of patients on study treatment at study end, that at Final Visit maintain glycaemic control (HbA1c <= 7.0%) without need for rescue medication and without > 2% weight gain (from V6 on) [ Time Frame: 432 weeks ]

Occurence of and time to composite endpoint of all CEC confirmed adjudicated events [ Time Frame: 432 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor

BMI =< 45kg/m²

age between >= 40 and =< 85 years

signed and dated written ICF

stable anti-diabetic background for at least 8 wks before study start

Exclusion criteria:

Type 1 diabetes

Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)

treatment with any anti-obesity drug less than 3 months before ICF

uncontrolled hyperglycemia

previous or planned bariatric surgery or intervention

current or planned system corticoid treatment

change in thyroid hormones treatment

acute liver disease or impaired hepatic function

pre-planned coronary artery revascularization within 6 months of ICF

known hypersensitivity to any of the components

Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information

congestive heart failure class III or IV

acute or chronic metabolic acidosis

hereditary galactose intolerance

alcohol or drug abuse

participation in another trail with IMP given 2 months before IMP start

pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control

patients considered reliable by the investigator

acute coronary syndrome =< 6 wks before ICF

stroke or TIA =< 3 months prior to ICF

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243424